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Product NDC Code | 11928-005 | ||||
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Drug Name | Mada 70% alcohol |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Mada Medical Products, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Alcohol Denat. 72% v/v
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply a small amount to palm. Briefly rub, covering hands with product until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Carbomer, Triisopropanolamine
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial Agent
Spl product data elements
Usually a list of ingredients in a drug product.Mada 70% Alcohol Alcohol WATER GLYCERIN PROPYLENE GLYCOL ISOPROPYL MYRISTATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE ISOPROPYL ALCOHOL CARBOXYPOLYMETHYLENE TRIISOPROPANOLAMINE ALCOHOL ALCOHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRODUCT CODE 705555 STORE BETWEEN 33 TO 110F MADA GEL 70% ALCOHOL QUANTITY AND SIZE 55 Gallon Drum BATCH NUMBER EXP: MANUFACTURED FOR: MADA MEDICAL 625 WASHINGTON AVE. CARLSTADT. NJ 07072 MADE IN USA Rev:01/18 container label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, contact a physician or poison control center.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.Avoid contact with eyes. If eye contact occurs, flush with water.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. FLAMMABLE Keep away from heat or flame. Avoid contact with eyes. If eye contact occurs, flush with water. Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician. Keep out of reach of children. If swallowed, contact a physician or poison control center.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API